The following data is part of a premarket notification filed by Contour Fabricators Of Florida, Inc. with the FDA for Rns Sterile, Disposable Radiographic Contrast Tray.
| Device ID | K955687 |
| 510k Number | K955687 |
| Device Name: | RNS STERILE, DISPOSABLE RADIOGRAPHIC CONTRAST TRAY |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | CONTOUR FABRICATORS OF FLORIDA, INC. 3340-D SCHERER DR. St. Petersburg, FL 33716 |
| Contact | Scott Williams |
| Correspondent | Scott Williams CONTOUR FABRICATORS OF FLORIDA, INC. 3340-D SCHERER DR. St. Petersburg, FL 33716 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-14 |
| Decision Date | 1996-06-03 |